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India was placed on a trade blacklist by the U.S. over concerns about the nation's lack of protection for pharmaceutical intellectual property. The Office of the U.S. Trade Representative released a Special 301 report objecting to aspects of the patent system of India. "The United States urges India instead to adopt policies that support both cutting-edge innovation to address important health challenges and a robust generic market," the report states.

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The U.S. Trade Representative refrained from demoting the status of India in its Special 301 report released Wednesday even though "the systemic pattern of undermining patented medicines in India warrant its elevation to Priority Foreign Country status," said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America. PhRMA acknowledged the need for the U.S. to get involved with India's incoming government, saying it will pave the way for constructive commitment on how the country's worsening intellectual property environment could be rectified.

India's Drug Controller General office announced plans to inspect all of the nation's clinical-trial sites at least annually to verify regulatory compliance. The inspections will cover Schedule Y drugs and cosmetics, good clinical practice and other regulatory requirements. The move follows criticism of the agency's failure to monitor human clinical trials more closely and is part of several other recent measures, including establishing an ethics committee and setting guidelines for compensation to those injured in clinical trials.

The China Food and Drug Administration has established new licensing requirements for the manufacture of high-risk excipients based on toxicity and dosage. The new rules are part of a broader effort to establish a drug master file system similar to the U.S. FDA's. The capacity of China's FDA to register and inspect pharmaceutical and excipient manufacturers is limited and would benefit from third-party audits and stronger self-policing, according to Meredith Ge, former chairwoman of the International Pharmaceutical Excipients Council, who spoke at IPEC-Americas' Excipient Fest in Baltimore.

India's recent landmark patent ruling correctly sets a high standard for innovative treatments, Cato Institute research fellow Swaminathan S. Anklesaria Aiyar writes. The court made it clear that it wasn't opposed to drug patents in general, he writes. PhRMA's Chip Davis called the verdict "another example of what I would characterize as a deteriorating innovation environment in India."

The NHS Technology Adoption Centre's work will be administered by the U.K.'s National Institute for Health and Care Excellence and will now be called Health Technologies Adoption Programme. The organization will link the NHS in England with medical-device companies and spur them to collaborate and address obstacles to technology adoption.